Successful implementation of safe practice for adult intravenous push medication in a tertiary care hospital: determination of stability of four intravenous antibiotics in syringes.

In 2017, a severe shortage of infusion bags resulted in a paradigm change in medication administration practice from intermittent infusion to intravenous push. The Institute for Safe Medication Practices proposed safe practice guidelines for adult intravenous push medications. A different study showed that ready-to-administer medication prepared in the sterile area of a pharmacy reduces the risk of harm, nurses' time for medication administration and the cost of medications. Based on the recommendation of the Institute for Safe Medication Practices, we decided to conduct a pilot study on the implementation of sterile compounding and administration of intravenous push medication in adult patients admitted to the hospital. In the study, the stability of five intravenous push antibiotic syringes was also determined in the syringes.

The Effects of Intravenous Fluid Viscosity on the Accuracy of Intravenous Infusion Flow Regulators.

Intravenous infusion flow regulators (IIFRs) are widely used devices but it is unknown how much the difference between the IIFR scale and the actual flow rate depends on the viscosity of the intravenous (IV) fluid. This study evaluated the effects of viscosity on the flow rate of five IV fluids (0.9% normal saline, Hartmann's solution, plasma solution-A, 6% hetastarch, and 5% albumin) when using IIFRs. The viscosity of crystalloids was 1.07-1.12 mPa·s, and the viscosities of 6% hetastarch and 5% albumin were 2.59 times and 1.74 times that of normal saline, respectively. When the IIFR scales were preset to 20, 100, and 250 mL/hr, crystalloids were delivered at the preset flow rate within a difference of less than 10%, while 6% hetastarch was delivered at approximately 40% of the preset flow rates and 5% albumin was approximately 80% transmitted. When delivering colloids, IIFRs should be used with caution.

Comparison of the effect of continuous intravenous infusion of sodium valproate and midazolam on management of status epilepticus in children.

BACKGROUND AND OBJECTIVES: Status epilepticus as a pediatric emergency requires rapid seizure control in order to prevent subsequent disabilities. Therefore, the present study was conducted to compare the efficacy and side effects of continuous intravenous infusion of sodium valproate versus midazolam as a third-line treatment of status epilepticus in children. METHODOLOGY: This randomized clinical trial study included all children with convulsive and non-convulsive status epilepticus admitted to the pediatric intensive care unit (PICU) of the Bu-Ali Sina Hospital in Sari City (Mazandaran Province, Iran) who had not responded to first-line treatment with diazepam and second-line treatment with phenytoin or phenobarbital. They were consequently treated with continuous intravenous infusion of sodium valproate or midazolam to control persistent seizures. RESULTS: The study comprised 70 patients who were randomly assigned to two equal groups of sodium valproate or midazolam treatment. The mean age of patients in group A (sodium valproate) and group B (midazolam) was 3.97 ± 3.33 and 3.84 ± 2.93 years, respectively. In the present study, the most common etiology of status epilepticus was remote symptomatic, accounting for 35% of cases in the two groups. Sodium valproate was effective in controlling status epilepticus in 91.4% of patients, while midazolam was found to be effective in 85.7% of patients (p > 0.05). Patients who received sodium valproate had shorter seizure duration after administration of the drug compared to those who received midazolam (p = 0.01). Eight patients in the midazolam group and two patients in the sodium valproate group were intubated (p = 0.023). The mean duration of stay in the PICU was 3.2 ± 1.4 and 5.6 ± 2.8 days in groups A and B, respectively, showing a significant difference (p = 0.001). CONCLUSION: According to our findings, intravenous infusion of sodium valproate can be used as an effective and relatively safe treatment in children with all types of status epilepticus, especially in challenging situations such as lack of intensive care units or respiratory problems.

Transition from Intravenous to Subcutaneous Daratumumab Formulation in Clinical Practice.

INTRODUCTION: Daratumumab is an anti-CD38 monoclonal antibody widely used for treating patients with newly diagnosed or relapsed/refractory multiple myeloma. The subcutaneous formulation of daratumumab was developed with the purpose of minimizing the treatment burden (to patients and health care system) associated with intravenous daratumumab. Given its recent approval, there is a knowledge gap regarding the best practices that should be instituted for safe administration of subcutaneous daratumumab. METHODS: A retrospective chart review was performed from August 2020 until November 2020 to identify patients either switched to or treated upfront (daratumumab naive) with any subcutaneous daratumumab-based treatment regimen. All patients received appropriate premedications per institutional standards of care. The study end points were to report real-world data regarding administration-related reaction rates (at or following discharge from infusion center), as well as compare their incidence rates to those noted in the COLUMBA study (historical cohort). RESULTS: The study included 58 patients, of whom 38% (n = 22) were daratumumab naive. The majority (84%, n = 49) received subcutaneous daratumumab in combination with various antimyeloma regimens. There were no cases of administration-related reactions at infusion center or after discharge irrespective of previous exposure to intravenous daratumumab. None of the patients included herein required rescue home medications or visited the emergency department within 24 to 48 hours after subcutaneous daratumumab administration. These translated into a significant difference in incidence of administration-related reactions compared with historical cohort (0% vs. 13%, P = .003). CONCLUSION: Subcutaneous daratumumab was extremely well tolerated and could be safely administered without need for monitoring or rescue home medications.

Home intravenous antibiotherapy and the proper use of elastomeric pumps: Systematic review of the literature and proposals for improved use.

Over several decades, the economic situation and consideration of patient quality of life have been responsible for increased outpatient treatment. It is in this context that outpatient antimicrobial treatment (OPAT) has rapidly developed. The availability of elastomeric infusion pumps has permitted prolonged or continuous antibiotic administration by dint of a mechanical device necessitating neither gravity nor a source of electricity. In numerous situations, its utilization optimizes administration of time-dependent antibiotics while freeing the patient from the constraints associated with infusion by gravity, volumetric pump or electrical syringe pump and, more often than not, limiting the number of nurse interventions to one or two a day. That much said, the installation of these pumps, which is not systematically justified, entails markedly increased OPAT costs and is liable to expose the patient to a risk of therapeutic failure or adverse effects due to the instability of the molecules utilized in a non-controlled environment, instability that necessitates close monitoring of their use. More precisely, a prescriber must take into consideration the stability parameters of each molecule (infusion duration, concentration following dilution, nature of the diluent and pump temperature). The objective of this work is to evaluate the different means of utilization of elastomeric infusion pumps in intravenous antibiotic administration outside of hospital. Following a review of the literature, we will present a tool for optimized antibiotic prescription, in a town setting by means of an infusion device.

Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety.

BACKGROUND: Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. AIM: The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature to better guide the selection of the most appropriate vascular access. METHODS: The project was conducted in three phases: (i) standardization of intravenous therapy, which was conducted using a modified double-round Delphi method; (ii) characterization of the dilutions agreed on in the previous phase by means of determining the osmolarity and pH of each of the agreed concentrations, and recording the vesicant nature based on the information in literature; and (iii) algorithm proposal for selecting the most appropriate vascular access, taking into account the information gathered in the previous phases. RESULTS: In total, 112 drugs were standardized and 307 different admixtures were assessed for pH, osmolarity and vesicant nature. Of these, 123 admixtures (40%), had osmolarity values >600 mOsm/L, pH < 4 or > 9, or were classified as vesicants. In these cases, selection of the most suitable route of infusion and vascular access device is crucial to minimize the risk of phlebitis-type complications. CONCLUSIONS: Increasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices.

Lidocaine Infusion for Refractory Pain from Rat Lungworm Disease - Honolulu, Hawai'i.

Human infection with Angiostrongyloides cantonensis, or rat lungworm disease, manifests most commonly with neurologic symptoms that often include severe diffuse pain. While pain is reported by the majority of patients with rat lungworm disease, there are presently no published guidelines on the approach to pain management for these patients. Here we report a case of rat lungworm disease where severe refractory pain was the most prominent symptom and an intravenous lidocaine infusion was used as a successful treatment modality. Intravenous lidocaine has been shown to be safe and effective in neuropathic pain, refractory cancer pain, and peri-operative pain management. To our knowledge, this is the first case report on the use of lidocaine infusion for the management of refractory pain from rat lungworm disease, and among the first reports of any approach, to pain management for rat lungworm disease. We suggest that a lidocaine infusion protocol be considered when pain from rat lungworm disease fails to respond to first-line analgesics.

Feasibility of Continuous Infusions of Acyclovir.

Current guidelines for severe herpes simplex virus infection recommend 21 days of intravenous therapy. The thrice-daily administration of intravenous acyclovir makes it challenging to deliver as outpatient therapy. We describe 2 cases with confirmed or presumed neonatal herpes simplex virus encephalitis treated with acyclovir administered as a continuous-infusion at home and review the pharmacologic and clinical evidence for continuous infusions of acyclovir.

AGA Clinical Practice Update on Management of Inflammatory Bowel Disease During the COVID-19 Pandemic: Expert Commentary.

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update was to rapidly review the emerging evidence and provide timely expert recommendations regarding the management of patients with inflammatory bowel disease during the coronavirus disease 2019 pandemic. This expert commentary was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely perspective on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology.

Continuous versus single shot adductor canal block for postoperative pain relief after total knee arthroplasty: A protocol for randomized controlled trial.

BACKGROUND: Adductor canal block has become a popular mode of pain management after total knee arthroplasty. This study compared a single-injection adductor canal block (SACB) with continuous adductor canal block (CACB). The hypothesis was that the 2 groups would have equivalent analgesia at 48 hours post-neural blockade. METHODS: This is a double-blinded, randomized, controlled, equivalency trial that is conducted at a single university hospital in China. A total of 60 patients who meet inclusion criteria are randomized in a ratio of 1:1 to either CACB (0.5% ropivacaine 20 mL followed by continuous infusion of 0.2% ropivacaine at 5 mL/h for 48 hours) or SACB (0.5% ropivacaine 20 mL) group. The primary outcome is pain scores at 48 hours utilizing the visual analog scale, whereas the secondary outcomes include opioid consumption, Timed Up & Go test, ambulation distances at discharge, length of stay, and maximal flexion at discharge. All pain scores are assessed by an independent observer who is blinded to the allocation of groups. RESULTS: This study has limited inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is expected to provide evidence of better therapy for the pain management after total knee arthroplasty. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5431).

Smile - Secure my intravenous line effectively: A pilot randomised controlled trial of peripheral intravenous catheter securement in paediatrics.

AIM: Evaluate the feasibility of an efficacy randomised control trial (RCT) of paediatric peripheral intravenous catheter (PIVC) securement to prevent failure without resultant skin damage. METHODS: A 3-arm, pilot RCT in an Australian paediatric hospital. Random assignment of 330 children to receive (i) bordered polyurethane dressing (BPU) + non-sterile foam (NSF), (ii) integrated securement dressing (ISD) + sterile foam (SF), or (iii) tissue adhesive (TA)+ NSF. Primary outcomes were feasibility and PIVC failure. Secondary outcomes included: skin/bloodstream infection; occlusion; infiltration; dislodgement; phlebitis; dwell; serious adverse events; acceptability and microbial colonisation of catheter tips, wound site, and foam. RESULTS: Most feasibility outcomes were confirmed; 98% of eligible patients consented, 96% received their allocated dressing and no patients were lost to follow up. Eligilbility feasibility (58%) was not met. 11 randomised patients did not require a PIVC. Of 319 patients receiving a PIVC (20,716 PIVC-hours), a significant reduction in PIVC failure was demonstrated with ISD, 31/107 (29%, p = 0.017) compared to BPU, 47/105 (45%). Although not statistically significant, compared to BPU, TA 34/107 (32%, p = 0.052) was associated with less PIVC failure. On Cox regression, no securement intervention significantly reduced PIVC failure. Older age (HR 0.92; 95% confidence interval [CI] 0.88-0.96; p = <0.01), no infection at baseline (HR 0.51; 95% CI 0.34-0.78) and insertion by vascular access specialist (HR 0.40; 95% CI 0.26-0.64) were significantly associated with reduced failure (p < 0.05). CONCLUSION: ISD and TA had reduced PIVC failure compared to BPU. A large efficacy trial to test statistical differences is feasible and needed.

Respiratory mechanics evaluation of mice submitted to intravenous methacholine: Bolus vs. continuous infusion.

IMPACT STATEMENT: Respiratory mechanics studies are associated with fundamental research and translational studies; the present work thus investigates this particular matter. Our current research describes differences and similarities between two different ways of administrating a very prevalent bronchoconstrictor (methacholine) in an aging process scenario. The core issue of our work is related with troubles we find with the bolus protocol and the application of the mathematical model used to assess the respiratory mechanics. Our findings reveal the continuous infusion as an alternative to these problems and we hope to provide the proper foundations to a more reliable assessment in the respiratory field.

Qualification of a chemotherapy-compounding robot.

KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.

Current trends in the acute treatment of ischemic stroke: analysis from the Paul Coverdell National Acute Stroke Program.

BACKGROUND: The intra-arterial treatment (IAT) of acute ischemic stroke (AIS) is now evidence-based and given the highest level of recommendation among eligible patients. Using a multi-state stroke registry, we studied the trend in IAT among patients with AIS over 11 years and its impact on the utilization of intravenous thrombolysis (IVT) within the same 11 years. METHODS: Using data from the Paul Coverdell National Acute Stroke Program (PCNASP), we studied trends in IVT and IAT for patients with AIS between 2008 and 2018. Trends over time were examined for rates of IVT only, IAT only, or a combination of IVT and IAT (IVT+IAT). Favorable outcome was defined as discharge to home. RESULTS: During the study period there were 595 677 patients (mean age 70.4 years, 50.4% women) from 646 participating hospitals with a clinical diagnosis of AIS in the PCNASP. Trends for IVT only, IAT only, and IVT+IAT all significantly increased over time (P<0.001). Total use of IVT and IAT increased from 7% in 2008 to 19.1% in 2018. The rate of patients discharged to home increased significantly over time among all treatment groups (P<0.001). CONCLUSION: In our large registry-based analysis, we observed a significant increase in the use of IAT for the treatment of AIS, with continued increases in the use of IVT. Concurrently, the percent of patients with favorable outcomes continued to increase.

Infusion-related reactions during Natalizumab treatment: Do we still need a post-infusion observation period?

BACKGROUND: Natalizumab (NTZ) is a humanized monoclonal antibody used in the treatment of relapsing remitting multiple sclerosis. Although NTZ is usually well-tolerated, infusion-related reactions (IRRs) may occur, and the patients have to be monitored during the infusion and for one hour afterwards. OBJECTIVE: To identify frequency and severity of IRRs during NTZ infusions and one-hour post-infusion observation period in a clinical practice setting. METHODS: Multicenter, observational study involving three Swiss (Lugano, St. Gallen and Luzern) and two Italian (Milano and Napoli) tertiary MS centers. Predisposing factors to IRRs were investigated using multivariate Cox regression models. RESULTS: A total of 11'133 infusions received by 302 MS patients were analyzed (68.9% females, median age 33.6 years, median EDSS 2.5). IRRs occurred in 24 (8%) patients during NTZ infusions and in 7 (2%) during one-hour post-infusion. Only 8 patients needed pharmacological treatment, of whom 7 during NTZ infusion. Age, sex and history of allergies were not associated with risks for IRR. The frequency of post infusion IRRs after the fifth cycle was low compared to that during the first four infusions (0.83% vs 0.06%). CONCLUSION: In our cohort, NTZ associated IRR mainly occurred during the infusion period compared to the one-hour observational period. Also, the first IRR exclusively occurred within the first 4 NTZ administrations. However, further multi-center studies with a larger sample size are needed to capture rare and serious events that could emerge during the observational period and to make clinical recommendations.